[Federal Register Volume 63, Number 94 (Friday, May 15, 1998)]
[Rules and Regulations]
[Pages 26983-26986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12851]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[FRL-6013-9]
Protection of Stratospheric Ozone; Methyl Bromide
AGENCY: Environmental Protection Agency.
ACTION: Notice of clarification.
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SUMMARY: This document clarifies a previous statement by EPA about the
applicability of a Clean Air Act labeling rule to methyl bromide as a
``class I ozone-depleting substance.'' The labeling rule requires
products ``containing'' or ``manufactured with'' a class I ozone-
depleting substance to be labeled as such. This document makes clear
that any product, including any agricultural product, that ``contains''
or is ``manufactured with'' methyl bromide is subject to the labeling
rule's requirements. At the same time, EPA is not aware of any
agricultural product that ``contains'' or is ``manufactured with''
methyl bromide, as those terms are defined by the labeling rule. In
particular, raw food commodities grown for the fresh food market and
produced with the use of methyl bromide do not meet the definitions of
products ``containing'' or ``manufactured with'' methyl bromide and are
thus not subject to the labeling rule's requirements.
DATES: The effective date of this Notice of Clarification is May 15,
1998.
ADDRESSES: Comments and data relating to the methyl bromide rule are
contained in Air Docket A-92-13, U.S. Environmental Protection Agency,
OAR Docket and Information Center, Room M-1500, 401 M Street, S.W.,
Washington, D.C. 20460. Comments and data relating to the labeling rule
are contained in Air Docket A-91-60, at the same location. Each of the
dockets may be inspected between 8 a.m. and 5:30 p.m. on weekdays. The
telephone number for the dockets is (202) 260-7548; the fax number is
(202) 260-4400. As provided in 40 CFR, Part 2, a reasonable fee may be
charged for photocopying.
FOR FURTHER INFORMATION CONTACT: Carol Weisner at (202) 564-9193 or fax
(202) 565-2096, Stratospheric Protection Division, USEPA, Mail Code
6205J, 401 M Street, SW., Washington, DC 20460. Overnight mail (Fed-Ex,
Express Mail, etc.) should be sent to our 501 3rd Street, NW.,
Washington, DC 20001 street address.
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SUPPLEMENTARY INFORMATION:
I. Background Information
A. Stratospheric Ozone Protection
Added in 1990, Title VI of the Clean Air Act (``CAA'' or ``Act'')
establishes a comprehensive program to protect stratospheric ozone,
which helps shield the earth from harmful ultraviolet radiation. In
particular, it requires EPA to list substances that have a significant
potential to deplete stratospheric ozone as class I ozone-depleting
substances, and to require their phaseout by a specified date. It also
provides for a multi-faceted regulatory program to minimize the use and
release of ozone-depleting substances prior to their phaseout.
B. Labeling Rule
Section 611 of the Act prohibits the introduction into interstate
commerce of any product containing a class I substance or manufactured
with a process using a class I substance, unless it bears a warning
statement indicating that the product contains or is manufactured with
ozone-depleting substances. To implement this and other provisions of
section 611, EPA issued a final rule on February 11, 1993, at 58 FR
8136, which established labeling requirements for, among other things,
products containing, or manufactured with a process that uses, a class
I ozone-depleting substance (the ``labeling rule.'')
The labeling rule defines a ``product containing'' a class I
substance as a ``product including, but not limited to, containers,
vessels, or pieces of equipment, that physically holds a controlled
substance [i.e., a class I or II ozone-depleting substance] at the
point of sale to the ultimate consumer which remains within the
product.'' The rule also defines ``manufactured with a controlled
substance'' as follows:
[T]he manufacturer of the product itself used a controlled
substance directly in the product's manufacturing, but the product
itself does not contain more than trace quantities of the controlled
substance at the point of introduction into interstate commerce. The
following situations are excluded from the meaning of the phrase
``manufactured with'' a controlled substance:
(1) Where a product has not had physical contact with the
controlled substance;
(2) Where the manufacturing equipment or the product has had
physical contact with a controlled substance in an intermittent
manner, not as a routine part of the direct manufacturing process;
(3) Where the controlled substance has been transformed, except
for trace quantities; or
(4) Where the controlled substance has been completely
destroyed.
The current labeling requirements are codified at 40 CFR Part
82, Subpart E (including sections 82.100-82.124).1
\1\ In a January 19, 1995, rulemaking (60 FR 4010), the labeling
rule was revised. Among other revisions, the definition of
``manufactured with'' was amended to indicate that a product
``manufactured with'' a controlled substance does not contain more
than trace quantities of the controlled substance. The definition
was also amended to expand the situations that are excluded from the
phrase ``manufactured with'' to include where a product has physical
contact with a controlled substance only in an intermittent manner
and not as a routine part of the direct manufacturing process and
where the controlled substance has been completely destroyed.
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Section 82.102(a) of the labeling rule specifically provides that,
in the case of any substance designated as a class I substance after
February 11, 1993, the labeling requirements are applicable beginning
one year after the designation of such substance, unless the rulemaking
designating such substance provides otherwise.
C. Methyl Bromide Rule
EPA issued a final rule on December 10, 1993, at 58 FR 65018,
pursuant to sections 602 and 604 of the CAA, listing methyl bromide as
a class I ozone-depleting substance and establishing a phaseout date
for its production and importation (the ``methyl bromide rule.'')
Methyl bromide is used as a pesticide and fumigant.
The labeling rule became applicable to methyl bromide on January 1,
1995, one year following the effective date of its designation as a
class I substance. In the preamble to the methyl bromide rule, EPA
discussed the applicability of the labeling rule to methyl bromide.
With respect to containers of methyl bromide, EPA stated that such
containers would be subject to the labeling rule. With respect to
agricultural products, EPA ``determined that activities involved in
growing, harvesting, storing and transporting food are part of an
agricultural process that falls outside the intent of Congress to
require labeling on products `manufactured with' a class I or II
substance'' (58 FR at 65043, col. 3.) Based on this determination, EPA
concluded that ``products treated with methyl bromide would not require
labeling.'' Id.
In reaching its conclusion, EPA recognized that ``the general
purpose of alerting consumers that certain goods were produced in a
manner that may cause harm to stratospheric ozone could apply to
certain agricultural products for which methyl bromide is used.'' Id.
The Agency nevertheless concluded that the labeling requirement
applicable to products ``manufactured with'' a class I substance was
reasonably interpreted not to apply to agricultural products because
``such products are grown and not manufactured.'' Id. EPA cited
Webster's Ninth New Collegiate Dictionary (1983) for the ordinary
definition of the word ``manufacture'' as making something from raw
materials by hand or by machinery, which would not include the growing
of fruits and vegetables. The Agency also stated that it believed
Congress did not anticipate labeling of raw agricultural products given
the practical difficulty of labeling such products, many of which are
sold without any packaging at all.
D. Litigation
In February, 1994, the National Resources Defense Council, together
with other parties, challenged this as well as other aspects of the
methyl bromide rule by filing a petition in the U.S. Court of Appeals
for the D.C. Circuit. EPA is issuing this clarification pursuant to a
settlement agreement in that case.
II. Clarification
The need for this clarification arises out of the breadth of some
of the Agency's statements taken out of context. In isolation,
statements that ``products treated with methyl bromide'' and
``agricultural products'' do not require labeling could be interpreted
to mean that any agricultural product is exempt from the labeling rule,
regardless of whether and how methyl bromide was used in its
production. EPA's discussion of the applicability of the labeling rule
to methyl bromide addressed specific activities and types of products.
Read in context, the Agency's statements are properly limited to the
specific activities and products it addressed. The purpose of this
notice is to confirm the limits of those statements and clarify the
extent to which the labeling rule is applicable to methyl bromide.
As noted above, EPA addressed specific activities and products in
its discussion of the labeling rule's applicability to methyl bromide.
The Agency determined that ``activities involved in growing,
harvesting, storing and transporting food'' do not constitute
manufacturing under the labeling rule, and that Congress did not intend
raw agricultural products such as fruits and vegetables to be labeled.
From those determinations, EPA concluded that ``products treated with
methyl bromide would not require labeling.''
EPA's conclusion is appropriate for the specific activities and
products addressed. Growing and harvesting, as the Agency explained, do
not constitute manufacturing, since they do not fit the
[[Page 26985]]
ordinary definition of manufacturing as making something from raw
materials by hand or by machinery. Indeed, agricultural crops are
generally considered ``raw materials'' that may or may not be made into
something else by hand or by machine. (See, for example, the definition
of ``raw material'' in Webster's Ninth New Collegiate Dictionary
(1990): ``wheat * * * is a raw material for the flour mill.'') As a
result, use of methyl bromide as a pesticide in growing a crop does not
make the harvested crop a product ``manufactured with'' methyl bromide.
Generally speaking, use of methyl bromide as a fumigant in storing
or transporting also does not make a product ``manufactured with''
methyl bromide. The labeling rule's definition of ``manufactured with''
specifies that the manufacturer of the product itself uses a class I
substance ``directly in the product's manufacturing.'' Storing and
transporting are generally not part of a direct manufacturing process,
although they may precede or follow such a process. By themselves,
storing and transporting also do not meet the ordinary definition of
manufacturing, since neither entails making something from raw
materials by hand or by machine. Instead, they simply provide for the
safekeeping or movement of a product, either raw or manufactured.
Further, the labeling rule requires that a product be labeled by
the time it enters interstate commerce (section 82.124.) If a product
has not been ``manufactured with'' methyl bromide by the time it enters
interstate commerce, it does not become ``manufactured with'' methyl
bromide by virtue of being treated with methyl bromide in storage or
shipment following its entry into interstate commerce. Section
82.104(n) of the rule defines the possible points of entry into
interstate commerce as the ``release of a product from the facility in
which the product was manufactured, the entry into a warehouse from
which the domestic manufacturer releases the product for sale or
distribution, and at the site of United States Customs clearance.''
Obviously, these points of entry will often precede storage or shipment
of a product in the United States.
In the methyl bromide rule preamble, EPA also discussed the
applicability of the labeling rule to particular products. The
particular products addressed by EPA--raw agricultural products,
including fruits and vegetables--result from particular activities that
EPA determined do not constitute manufacturing--growing, harvesting,
storing and transporting. It thus follows that they are not products
``manufactured with'' methyl bromide.
For the reasons given above, EPA believes that its discussion in
the methyl bromide rulemaking of the labeling rule's applicability to
methyl bromide was appropriate for the specific activities and products
addressed. However, some members of the public have raised concerns
that the discussion may be read to imply that an agricultural product
is not subject to the labeling rule even when it contains or is
manufactured with methyl bromide. The point of today's notice is to
remove any such inadvertent implication.
The labeling rule applies to any product that ``contains'' or is
``manufactured with'' a class I ozone-depleting substance. Methyl
bromide has been classified as a class I ozone-depleting substance.
Therefore, any product containing or manufactured with methyl bromide
is subject to the labeling rule's requirements in the same way as a
product containing or manufactured with any other class I substance.
For the reasons stated above, use of methyl bromide in growing,
harvesting, storing or shipping a crop does not constitute
``manufacturing with'' methyl bromide and so would not subject the crop
to the labeling requirement for products ``manufactured with'' a class
I substance. But use of methyl bromide in the direct manufacturing
process of a product would subject that product to the requirement.
EPA, however, is not aware of any agricultural product that
``contains'' or is ``manufactured with'' methyl bromide, as those terms
are defined by the labeling rule. The definition of ``product
containing'' specifies that the product ``physically holds a controlled
substance at the point of sale.'' To EPA's knowledge, no agricultural
product so holds methyl bromide, nor is it likely that any would, given
the volatility of methyl bromide. One of methyl bromide's advantages as
a pesticide and fumigant is that it leaves virtually no residues on or
in products treated with it. In any event, section 82.106(b)(1) of the
labeling rule exempts from its requirements products containing no more
than trace quantities of a controlled substance remaining as a residue
where the controlled substance serves no useful purpose in or for the
product itself. With respect to containers of methyl bromide itself,
EPA made clear in the methyl bromide rule that such containers are
subject to the labeling requirement for products ``containing'' a class
I substance.
As noted above, EPA is also not aware of any agricultural products
``manufactured with'' methyl bromide. EPA has issued several
applicability determinations related to the labeling rule. Five of them
addressed whether particular uses of a class I substance constitute
``manufacturing with'' the substance. EPA found that these particular
uses did not constitute ``manufacturing with'' a class I substance
because the class I substance did not have physical contact with the
product or was used in an intermittent, non-routine manner (which
section 82.104(o)(2) of the rule exempts from the definition of
``manufactured with.'') These applicability determinations are
available in the docket for the labeling rule.
Methyl bromide is currently used as a post-harvest pest control
tool for raisins. Grapes are typically allowed to dry in the field and
are harvested as raisins. They are then typically sold to a packer who
treats the raisins with methyl bromide when held in storage. This use
of methyl bromide would not require that the raisins be labeled.
Storage of the raisins is not manufacturing, nor is it a part of any
manufacturing process. Moreover, storage generally occurs after the
raisins have been introduced into interstate commerce.
In the case of other dried fruits and nuts, methyl bromide is used
in a similar manner. To EPA's knowledge, methyl bromide is not a direct
part of any dried fruit or nut ``manufacturing'' process, but is used
as a storage or pre-shipment pest control tool. Since these uses are
not part of a direct manufacturing process, labeling is not required.
Methyl bromide is also used to treat empty food processing
facilities for pest control. An example of such use is the periodic
fumigation of flour mills when they are empty. In these cases, food
products are typically removed from the facility prior to the methyl
bromide treatment, which takes place on an as-needed basis (typically
once or twice a year, depending on pest levels.) The methyl bromide
used in these cases has no physical contact with any food products that
are manufactured in the facility, so labeling is not required. Even if
food products were present in the facility during the methyl bromide
treatment, labeling would not be required if the treatment is done on
an intermittent or infrequent basis.
EPA may not be aware of the details of all of the processes
involving use of methyl bromide. There may be uses that are part of the
direct manufacturing process for a product and that are not otherwise
exempt from the labeling rule's definition of ``manufactured
[[Page 26986]]
with.'' Any such use of methyl bromide would subject the resulting
product to the labeling rule. Similarly, any product ``containing''
methyl bromide, as that phrase is defined by the labeling rule, is
subject to the rule.
III. Submission to Congress and the General Accounting Office
The Congressional Review Act (``Act''), 5 U.S.C. section 801 et
seq., as added by the Small Business Regulatory Enforcement Fairness
Act of 1996, does not apply because this action is not a rule.
IV. Additional Information
For more information on methyl bromide, please contact the
Stratospheric Protection Hotline at 1-800-296-1996, Monday-Friday,
between the hours of 10:00 a.m. and 4:00 p.m. (EST). Federal Register
publications can be ordered from the Government Printing Office Order
Desk (202) 783-3238; the citation is the date of publication. Each of
the final rules referred to in this Notice may also be retrieved from
EPA's Ozone Depletion World Wide Web site, at http://www.epa.gov/docs/
ozone/ .
List of Subjects in 40 CFR Part 82
Environmental protection, Administrative practice and procedure,
Air pollution control, Reporting and recordkeeping requirements.
Dated: May 8, 1998.
Richard D. Wilson,
Acting Assistant Administrator for Air and Radiation.
[FR Doc. 98-12851 Filed 5-14-98; 8:45 am]
BILLING CODE 6560-50-P
